Europe’s revolutionary BPA proposal puts more scrutiny on US regulatory inaction
“We're the ones who aren't being protective enough in the U.S.”
If a scientific opinion recently proposed by European officials is upheld, the recommended daily dose of bisphenol-A, or BPA, in Europe will be more than a million-fold lower than what U.S. regulators say is safe.
And the change in accepted exposure would all but ensure the chemical cannot be used in any food contact products.
“There's nothing different about the physiology of an American compared to a European,” Laura Vandenberg, a professor at University of Massachusetts Amherst School of Public Health & Health Sciences, told EHN. “So, if it's hazardous in Europe, it's hazardous for us.”
A significant gap already existed between the European Union and the U.S. in what regulators considered a safe dose of the plastic additive commonly used in everything from can linings to plastic water bottles. The draft opinion, released in December by the European Food Safety Authority, or EFSA, is “just moving it all the way to the left,” said Vandenberg. She added that their conclusion is “very solidly backed up by science,” and, in fact, has been now for at least a decade.
“And it’s really different compared to the FDA [U.S. Food and Drug Administration],” she said.
BPA is an endocrine disruptor, meaning it alters the proper functioning of our hormones, and is linked to a host of health problems, including cancer, diabetes, obesity, reproductive, nervous and immune system impacts, and behavioral problems. Scientists like Vandenberg have published studies on such health effects for decades.
So, that begs the question: How can two major regulatory bodies look at the science and come to such vastly different conclusions? Where is the disconnect?
Different approaches to testing BPA impacts
BPA testing in the lab of Cheryl Rosenfeld, a University of Missouri researcher. (Credit: Cheryl Rosenfeld)
Historically, the U.S. FDA has leaned almost exclusively on so-called “guideline” studies in determining what amount of exposure to traditional toxics—whether that’s lead or PFAS (perfluoroalkyl and polyfluoroalkyl substances) or BPA—is safe for people. These studies are typically done by government scientists and follow a prescription for everything from the type of animal to use to how long the animal is exposed. There is also a standard set of endpoints such as the weight of the organs.
This prescription was based on assumptions made decades ago about how toxic chemicals affect the body. Not all of these assumptions have stood the test of time, including the idea that a chemical’s toxicity is always proportional to the dose of exposure. In fact, research finds that sometimes a relatively high dose of some hormone-mimicking chemicals can prove innocuous for a given endpoint while a far lower dose wreaks havoc on the body.
Academic scientists tend to take a different, more investigative approach. They might look at changes in specific regions of the brain, or for alterations in behavior. All told, academics have published thousands of peer-reviewed studies, many of which have found negative health effects of BPA, even at very low doses.
In their assessment of BPA, EFSA went beyond guideline studies and considered evidence from academics, including many epidemiological studies and other laboratory-based studies that didn’t follow the standardized formula. Edward Bray, a spokesperson for the agency, noted that the key study driving their decision was published in 2016 by a team of academic scientists in China. That data linked BPA exposure in lab mice to an increase in the number of a type of immune cell, which can lead to the development of allergic lung inflammation.
“We need to acknowledge that if another agency has looked at these data and is drawing a conclusion that's intended to protect public health, then we're the ones who are behind,” said Vandenberg. “We're the ones who aren't being protective enough in the U.S.”
Many U.S. health professionals want to change that: last month, a group of scientists, doctors, and environmental and health organizations petitioned the FDA to review the safety of BPA and to remove or restrict approvals for the chemical in light of the European recommendations.
Maricel V. Maffini, a consultant to the Environmental Defense Fund, was among the signees of the petition. The agency is obligated to respond to the petition within 180 days, she told EHN. If they deny the petition, “they have to explain themselves,” said Maffini.
“Clarity” on BPA elusive in U.S.
The ripple effects of EFSA’s move could be great. Many U.S. manufacturers produce products to be sold worldwide. If they want to keep the European market, and the proposal goes through, they will need to meet the new, more stringent limits. Experts also believe that this move could lead to tighter regulations in the U.S. “I think this is going to put enormous pressure on the FDA. It’s about time,” Pat Hunt, a geneticist at Washington State University in Pullman, Wash., told EHN. In an emailed statement to EHN, the FDA said that their “regulatory decisions remain grounded in the robust evaluation of the totality of the available science on the use of food additives, including substances used in food packaging.” The agency noted that they had yet to complete their review of EFSA’s draft proposal.
Jennifer Garfinkel, director of product communications for the American Chemistry Council, which represents chemical manufacturers, told EHN that they, too, are currently analyzing the draft.
“BPA is one of the most widely studied chemicals used today,” she added in an emailed statement. “In 2018, the [FDA] published its findings from the Clarity Core Study, the largest study ever conducted on BPA. This study along with many others confirmed that BPA is safe at the very low levels to which consumers are exposed.”
Importantly, the study that Garfinkel referenced was part of a larger collaboration on the health effects of BPA: the Consortium Linking Academic and Regulatory Insights on BPA Toxicity, or Clarity. The unprecedented multimillion-dollar project was the subject of a four-part series published in November 2019 by EHN that found the FDA stacked the deck against such findings from independent scientists studying BPA – as well as many compounds used in "BPA-free" products.
Clarity aimed to synthesize a traditional regulatory study from the government and investigational studies from academics. The “core study” was the government’s contribution. Meanwhile, the studies published by academics showed health consequences—such as mammary gland cancer, kidney damage, increased body weight, and altered gene expression in the brain—after exposures to exceptionally low doses BPA. And when Vandenberg and her colleagues, all not involved in Clarity, took a close look at the government’s core study results, they identified 41 endpoints with statistically significant effects, too. A final 122-page “compendium of published findings” was released by the government in October, which summarized and collated all of the government and academic findings. It did not attempt to integrate or interpret those findings.
However, when the draft of the Clarity Core Study was published in 2018, the FDA released a statement highlighting the agency’s interpretations: they wrote that the study supported their ongoing stance that “currently authorized uses of BPA continue to be safe for consumers.” The statement made no mention of significant findings of effects at low doses of BPA in both the Core Study and in the peer-reviewed studies from academic collaborators that had been published by that time.
BPA alternatives excluded
Among the hazard endpoints identified by EFSA is actually one from the Clarity Core Report. Still, most of the information they used came from academic studies, noted Maffini. “They used everything they could get their hands on,” she said. “So, the spectrum of information was very different from what the FDA usually looks at.”
Bray confirmed that EFSA considered all the Clarity studies, including the academic contributions, in coming to their conclusion. Also, while EFSA’s mandate was to look solely at BPA, Bray added that, moving forward, the agency did recommend the collection of data on the use of BPS—a BPA alternative that has been linked to similar health impacts—in plastic food contact material, as well as its presence in and migration into food.
The European rule would only apply to food and beverage contact materials, and not the other uses of BPA such as in-store receipts and dental sealants. It also would not apply to a growing list of replacements, such as bisphenol-S (BPS). Many such chemical cousins are now regularly used in popular products labeled as BPA-free.
“The rest of them are just as bad, some are even worse,” said Hunt. “This is insidious business.”
EFSA is accepting public comments on the draft proposal until February 22. Once finalized, the assessment will inform decisions taken by EU risk managers in the European Commission, European Parliament and member states.
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